THE EFFECT OF BITTER ORANGE OIL INHALATION AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- fatigue severity in score
研究概览
简要总结
This study will be conducted to examine the effect of bitter orange oil inhalation aromatherapy on sleep quality and fatigue levels in patients with Type 2 Diabetes Mellitus (DM). The study will be conducted in the Endocrinology clinic of a university hospital in Türkiye. The research sample will consist of 100 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. Patients in the intervention group will have three drops of bitter orange oil placed on a small cotton ball each night close to bedtime for three consecutive days. They will then hold the cotton ball 5 cm away from their nose and inhale it for one minute while breathing normally. After three consecutive nights of this procedure, sleep quality and fatigue levels will be measured on the morning of the fourth day. Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being over the age of 19,
- •having no communication problem, and voluntarily agreeing to participate in the research,
- •having been admitted to the clinic at least 24 hours ago,
- •not having a diagnosed sleep disorder,
- •not having a psychiatric disorder requiring treatment,
- •not using narcotic drugs in the last 4 hours,
- •not eating two hours before going to bed at night,
- •not being pregnant,
- •not smoking,
- •not diagnosed acute rhinitis, sinusitis, or history of loss of smell.
排除标准
- •being under the age of 19,
- •not being conscious, refusing to participate in the research or opting to leave the study at any point,
- •having a diagnosed sleep disorder.
研究组 & 干预措施
Bitter orange oil group
Individuals in this group will receive inhalation of bitter orange peel oil for three consecutive nights.
干预措施: bitter orange oil group (Other)
Control group
Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.
结局指标
主要结局
fatigue severity in score
时间窗: 5 months
The Fatigue Severity Scale is a one-dimensional scale where individuals indicate how much they agree with each item by choosing a number from 1 to 7. 1 means completely disagree, and 7 means completely agree. The scale consists of 9 questions, with a score range of 9-63. A score of 36 or higher indicates severe fatigue. The total score is calculated by averaging the scores of all 9 items.
Sleep Quality in score
时间窗: 5 months
Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.
次要结局
- blood sugar level(5 months)
研究者
Dilek Yilmaz, PhD
Associate Professor, Bursa Uludag University, Department of Nursing
Uludag University